Medical Device Associate

ProductLife France; Courbevoie; Hybrid; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Hybrid & flexible working

Continuous learning

International environment

Career growth

Job summary

ProductLife Group is seeking a Medical Device Associate to support regulatory and quality activities for medical devices across international markets. You will work on MDR/IVDR compliance, Technical Documentation, CAPA, and audit support in a dynamic global team.

The role requires a Life Sciences degree, experience in regulatory affairs, and fluency in French and English. Hybrid & flexible working is offered with continuous learning opportunities and international exposure.

Qualifications

• Experience in Medical Device Regulatory Affairs and/or Quality Assurance.
• Knowledge of MDR, IVDR, ISO 13485 and Technical Documentation.
• Excellent organizational and communication skills.
• Fluent in French and English.

Responsibilities

• Support regulatory affairs activities for medical devices across international markets.
• Prepare, maintain, and review quality documentation including SOPs, working instructions, and templates.
• Contribute to the preparation and maintenance of Technical Documentation, STEDs, and Declarations of Conformity.
• Review Labelling and advertising documents.
• Support CAPA management, non-conformity investigations, and quality improvement activities.
• Participate in internal and external audits, including ISO 13485-related activities.
• Support regulatory registration and approval activities, including EU and FDA-related projects.
• Monitor regulatory developments and assess their impact on projects and processes.
• Contribute to KPI tracking and reporting through PLG systems and tools.
• Collaborate with cross-functional and international teams to deliver high-quality client services.

Skills

Regulatory Affairs

Quality Assurance

MDR/IVDR

ISO 13485

Technical Documentation

Education

Bachelor's degree in Life Sciences

Regulatory Affairs Certification

Job description

Make a meaningful impact on global healthcare — and grow your career while doing it. At ProductLife Group, you’ll join an innovative, forward‑thinking team operating across the world to shape the future of life sciences through expertise, collaboration, and purpose‑driven work.

Job Description : About ProductLife Group

ProductLife Group (PLG) is a global consulting organization supporting pharmaceutical, biotech, and medical device companies throughout the product lifecycle. Our mission is to improve human health by helping clients achieve and maintain regulatory compliance worldwide.

Your Mission

As a Medical Device Associate, you will support regulatory and quality activities for medical devices, ensuring compliance with international regulations and quality standards while contributing to a wide range of client projects.

Key Responsibilities

• Support regulatory affairs activities for medical devices across international markets.
• Prepare, maintain, and review quality documentation including SOPs, working instructions, and templates.
• Contribute to the preparation and maintenance of Technical Documentation, STEDs, and Declarations of Conformity.
• Review Labelling and advertising documents.
• Support CAPA management, non-conformity investigations, and quality improvement activities.
• Participate in internal and external audits, including ISO 13485-related activities.
• Support regulatory registration and approval activities, including EU and FDA-related projects.
• Monitor regulatory developments and assess their impact on projects and processes.
• Contribute to KPI tracking and reporting through PLG systems and tools.
• Collaborate with cross-functional and international teams to deliver high-quality client services.

Profile

• Bachelor's degree in Life Sciences, Pharmacy, Biomedical Engineering, Regulatory Affairs, or a related scientific field.
• Experience in Medical Device Regulatory Affairs and/or Quality Assurance.
• Knowledge of MDR, IVDR, ISO 13485, Technical Documentation, CAPA, and quality systems.
• Excellent organizational and communication skills.
• Fluent in French and English.
• Proactive, detail-oriented, and able to work in an international environment.

Why Join PLG?

• Work on international and innovative medical device projects.
• Collaborate with regulatory and quality experts worldwide.
• Benefit from continuous learning and professional growth opportunities.
• Join a dynamic company committed to improving patient access to safe healthcare solutions.

PLG partners with Life Sciences innovators to bring new medicines and technologies to patients, faster.

Join a fast-growing, entrepreneurial company where your expertise makes a difference from day one.

• A path for every career stage, from graduate to senior expert
• Exciting, high-impact projects with leading life sciences clients
• International by design
• Hybrid & flexible working
• Continuous learning
• An inclusive & diverse culture